{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T19:51:46Z","timestamp":1790711506308,"version":"4.1.0"},"reference-count":44,"publisher":"SAGE Publications","issue":"12","license":[{"start":{"date-parts":[[2022,6,28]],"date-time":"2022-06-28T00:00:00Z","timestamp":1656374400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Celgene International II","award":["The ozanimod RMS trials were supported by Celgene"],"award-info":[{"award-number":["The ozanimod RMS trials were supported by Celgene"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Mult Scler"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To characterize long-term safety and efficacy of ozanimod.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Patients with relapsing MS who completed a phase 1\u20123 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0.92\u2009mg\/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>This analysis included 2494 participants with mean 46.8 (SD 11.9; range 0.033\u201262.7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85.9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11.9%) had a serious TEAE, and 75 (3.0%) discontinued treatment due to TEAEs. Serious infections (2.8%), herpes zoster infections (1.7%), confirmed macular edema cases (0.2%), and cardiac TEAEs (2.8%) were infrequent. Adjusted annualized relapse rate was 0.103 (95% confidence interval, 0.086\u20120.123). Over 48\u2009months, 71% of patients remained relapse free. Adjusted mean numbers of new\/enlarging T2 lesions\/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This long-term extension of ozanimod trials confirmed a favorable safety\/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13524585221102584","type":"journal-article","created":{"date-parts":[[2022,6,29]],"date-time":"2022-06-29T01:15:13Z","timestamp":1656465313000},"page":"1944-1962","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":46,"title":["Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Up to 5\u2009years of follow-up in the DAYBREAK open-label extension trial"],"prefix":"10.1177","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7689-2533","authenticated-orcid":false,"given":"Bruce AC","family":"Cree","sequence":"first","affiliation":[{"name":"Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof W","family":"Selmaj","sequence":"additional","affiliation":[{"name":"Center for Neurology, \u0141\u00f3d\u017a, Poland and Collegium Medicum, Department of Neurology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Steinman","sequence":"additional","affiliation":[{"name":"Department of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, 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Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Peter","family":"Hartung","sequence":"additional","affiliation":[{"name":"Department of Neurology, Medical Faculty, Heinrich-Heine University, D\u00fcsseldorf, Germany\/Brain and Mind Centre, The University of Sydney, Sydney, Australia\/Department of Neurology, Medical University of Vienna, Vienna, Austria\/Department of Neurology, Palacky University Olomouc, Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Montalb\u00e1n","sequence":"additional","affiliation":[{"name":"Department of Neurology-Neuroimmunology, Centre d\u2019Esclerosi M\u00faltiple de Catalunya (Cemcat), Hospital Universitari Vall d\u2019Hebron, Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva K","family":"Havrdov\u00e1","sequence":"additional","affiliation":[{"name":"Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, 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